End-Stage Renal Disease Intra-dialysis Lifestyle Education Study (END-IDLE)

July 13, 2017 updated by: Gurjeet Birdee, Vanderbilt University Medical Center
The purpose of this study is to compare the effects of intra-dialysis yoga to an educational program among patients with end-stage renal disease. The investigators hypothesize that yoga as compared to the educational program will significantly improve quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators propose a prospective, randomized clinical trial among on maintenance hemodialysis to compare the effects of intra-dialysis yoga to an educational program. In a sample of 68 patients the investigators will compare the clinical effects of a 12-week program of yoga to a 12-week education program during dialysis. Outcome assessment of study participants will occur at baseline, 6-weeks, 12-weeks, and 24 weeks for: disease-related quality of life (physical component primary outcome of the study), physical performance, blood pressure, fatigue, satisfaction with dialysis, sleep quality, and mood. Among a sub-sample of 20 participants, the investigators will measure the potential effects of the interventions on endothelial function, arterial stiffness, and autonomic tone. The sub-study will collect outcomes at baseline and 12 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Maintenance hemodialysis for ≥3 or months
  • Adequately dialyzed (Kt/V ≥1.2 measured within last 3 months)
  • Expected to remain in present hemodialysis shift for next 4 months
  • Expected to remain on hemodialysis for at least 6 months
  • 18 years or older

Exclusion Criteria:

  • Acute or chronic medical conditions that would make intra-dialysis yoga potentially hazardous
  • Unstable cardiac disease e.g. angina, life threatening arrhythmia
  • Chronic lung disease that prevents gentle exercise or deep breathing exercises
  • Active cerebrovascular disease
  • Major depression
  • Chronic symptoms of nausea, vomiting, or diarrhea
  • Current participation in exercise or mind body program/practice
  • Cognitive impairment (MME ≤ 24) measured at baseline testing visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intra-dialysis yoga
The experimental intervention in this study is intra-dialysis yoga.
Behavioral: Intradialysis-yoga
The experimental intervention in this study is intra-dialysis yoga. The intra-dialysis yoga protocol consists of yoga instruction and practice being offered three times a week for 12 weeks. Subjects will have the opportunity to participate in 15 to 60 minutes of yoga during dialysis.
Active Comparator: Educational program
The active comparator for the study is an educational program.
Behavioral: Educational program
The educational intervention in this study consists of 12 modules of an educational course, Kidney School, developed and maintained by the Medical Education Institute, Inc. Kidney School is a comprehensive, free, educational curriculum for people with kid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks.
Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks
The Kidney Disease Quality of Life-36 instrument is a 36-item instrument that contains a generic core (Short Form-12) plus the burden of kidney disease, symptoms/problem of kidney disease, and effects of kidney disease scales.
Baseline, 6 weeks, 12 weeks, and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Assessment of Chronic Illness Therapy-Fatigue
Time Frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess fatigue among chronic disease patients
Baseline, 6, 12, and 24 weeks
Profile of Mood States
Time Frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess emotional states
Baseline, 6, 12, and 24 weeks
Center for Epidemiological Studies Depression
Time Frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess depressive symptoms
Baseline, 6, 12, and 24 weeks
End-stage renal disease: Patient satisfaction
Time Frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess patient satisfaction with dialysis treatment
Baseline, 6, 12, and 24 weeks
Pittsburgh Sleep Quality Index
Time Frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess sleep quality
Baseline, 6, 12, and 24 weeks
Self-efficacy for self-management
Time Frame: Baseline, 6, 12, and 24 weeks
Questionnaire to assess self-efficacy for self-management
Baseline, 6, 12, and 24 weeks
6-minute walk test
Time Frame: Baseline, 12, and 24 weeks
Assessment of physical performance
Baseline, 12, and 24 weeks
Blood pressure
Time Frame: Baseline and weekly over 12 week study period
Baseline and weekly over 12 week study period
Measure of endothelial function with flow-mediated vasodilatation
Time Frame: Baseline and 12-weeks
Sub-set of patients will have this assessment of endothelial function which measures percentage change in diameter measured in millimeters
Baseline and 12-weeks
Measure of arterial stiffness from radial artery based pulse wave analysis
Time Frame: Baseline and 12-weeks
Sub-set of patient will have this assessment of arterial stiffness as augmentation index
Baseline and 12-weeks
Autonomic tone
Time Frame: Baseline and 12-weeks
Assessment of cardiovagal and sympathoneural functioning including baroreflex and heart rate variability
Baseline and 12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gurjeet S Birdee, MD MPH, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 141325
  • K23AT006965 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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